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The COVID-19 pandemic has enabled startups that treat people with opioid use disorder to go totally virtual. That could change.

Photo: Craig F. Walker/The Boston Globe via Getty Images
Pandemic waivers made it easier to get treatment for opioid addiction. That could all go away next month.
Politics

Pandemic waivers made it easier to get treatment for opioid addiction. That could all go away next month.

Waivers on telehealth restrictions have opened the door to a previously unattainable type of care for people with opioid use disorder. Will they stick?

In the early months of 2020, Stephanie Strong had modest ambitions for her startup, Boulder Care, a telehealth company that treats people who are addicted to opioids. The company had begun seeing patients in October 2019, and, this year, if all went according to plan, Strong expected that Boulder would have a limited number of patients in Alaska, where the company had just struck a deal with Premera, the largest insurer in the Pacific Northwest.

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This year, all has not gone according to plan. When the COVID-19 pandemic hit, the telehealth market exploded, thanks to a combination of stay-at-home orders and regulatory waivers that instantly boosted mainstream providers like Teladoc and Doctor on Demand. But for Boulder and the small cohort of startups like it, the public health emergency did more than just bring in more business. It opened the door to a previously unattainable type of care for people with opioid addiction that advocates and health care professionals have been championing for years.

Boulder treats patients through a combination of coaching and a drug called buprenorphine. In normal times, the law requires doctors to get preauthorized and meet with their patients in person before they can prescribe it. Strong and others argue those obstacles prevent people from getting care at the moment they need it, particularly in places where there aren't many authorized physicians. "That critical moment where someone is really ready for care, that's where we want to create that onramp," Strong said.

But when COVID-19 hit, the government lifted the in-person visit requirement, meaning that now, Boulder can onboard patients fully remotely. The switch changed Boulder's entire growth trajectory, enabling it to expand beyond a corner of the Alaskan market to all of Alaska, Oregon and Washington.

Ophelia, a similar, Philadelphia-based startup that offers what's known as medication-assisted treatment for opioid use disorder, also felt a boost: It launched in April and is already seeing 130 patients across Pennsylvania and New York. "You have a huge population of people living in rural America who don't have access to treatment at all, and we wouldn't have been able to treat them without the regulatory changes," said Zack Gray, Ophelia's co-founder and CEO. "We would have had to be set up in urban hubs, which would have likely been Philadelphia or Pittsburgh, but definitely not Pottsville."

But the strides the industry has made these last five months may not last. The federal public health emergency declaration that gave rise to these changes is set to expire in late October. Barring an extension, the telehealth waivers could expire along with it. Now, virtual care companies, advocacy groups and even some lawmakers are using this moment to amplify the call to make these changes permanent. "The need for this access to care was evidenced even prior to the pandemic. The pandemic just made it all the more urgent," said Libby Baney, a partner specializing in digital health at the law firm Faegre Drinker and a senior adviser to The Alliance for Safe Online Pharmacies. "Now, the question is: Do we go back?"

The restrictions on telehealth services for medication-assisted treatment date back to 2008, when Congress passed the Ryan Haight Act, named for an 18-year-old who died of an overdose after buying Vicodin online. That law established the in-person visit requirement for controlled substances but gave the Drug Enforcement Administration the authority to create a special registration for telemedicine providers.

More than a decade later, the DEA has yet to create such a process. In the meantime, the telehealth industry has grown dramatically — as has the opioid crisis, which kills about 70,000 Americans a year. "These laws were made before the age of telehealth," Gray said. "They just haven't evolved."

The DEA isn't the only one with the power to change the status quo. In Congress, Republican Sen. Rob Portman and Democratic Sen. Sheldon Whitehouse have put forward a bipartisan bill called the TREATS Act, which would make the waivers on in-person visits for medication-assisted treatment permanent. "As we move forward and look to life beyond this pandemic, we must make sure that the advances to care and access that telehealth is currently providing is not lost, and that's exactly what this bill will do," Portman said in a statement when the bill was introduced in June.

That bill has received the backing of a broad coalition of health care organizations, including the American Psychiatric Association and the American Society of Addiction Medicine, among others. "Without the swift passage of the TREATS Act, the Trump administration's actions to waive certain telehealth-related restrictions due to COVID-19 may soon expire," the Coalition to Stop Opioid Overdose wrote in a July letter to the leaders of the House and Senate. "If Congress were to let that happen, then patients could experience an abrupt and needless disruption in the delivery of lifesaving addiction care through telehealth."

The TREATS Act has yet to go anywhere in Congress. Even if it did, there would still be state laws and procedures to contend with. That is where Boulder has been spending a lot of its time. Despite federal regulatory waivers, some states still have onerous, conflicting policies on the books regarding virtual care. In the early days of the pandemic in Alaska, Boulder found that despite the federal waivers, local laws were still preventing people in the state from getting onboarded virtually. "I had a woman call from a remote part of Alaska, and we could not see her, because we had to have that in-person visit prior to her engaging in our treatment," said Kara Nelson, Boulder's supervisor of peer coaching.

Nelson, who, like all of Boulder's peer coaches, is in recovery herself, testified before Alaska's Medical Board in favor of lifting in-person visit requirements during COVID-19, which the board eventually did. In Oregon, meanwhile, Boulder has successfully petitioned the Health Authority to intervene in a case where a patient's insurer was denying coverage of her medication.

"We know where these regulations came from, but it's time to revisit them and annihilate those barriers," Nelson said.

There is, of course, a reason these laws exist, including at the federal level. There are plenty of bad actors on the internet eager to push pills to strangers without any oversight. But defenders of virtual care say that the bad guys are doing that already, both online and off. If anything, tracking that bad behavior may be easier in a world where everything is digitized, says Andrey Ostrovsky, former chief medical officer for the Centers for Medicaid and Medicare Services and a current Boulder investor. "We need to make sure, just like brick and mortar, that there isn't garbage care being provided," Ostrovsky said. "With virtual care, we have much more digital exhaust to use for fraud detection and quality measurement than we do for brick and mortar services."

The question isn't whether making these waivers permanent for telemedicine providers would lead to abuse. It's whether it would lead to more abuse than previously existed — and whether that abuse would outweigh the benefits to patients. For a long time, it was impossible to know the answer to that question. But these last few months, as companies like Ophelia and Boulder have operated without some of those restrictions, it's created something of a natural experiment. Baney calls it "a pandemic pilot program" and says it should guide the decisions regulators and lawmakers make about how to proceed.

"We did waive those rules. We created access channels. Companies were able to come in and serve patients legitimately through telehealth," Baney said. "What did the data show?"

For now, at least, the data shows that telehealth hasn't been a cure-all for the opioid crisis. According to the American Medical Association, more than 40 states have reported an increase in opioid-related mortality since the onset of the COVID-19 pandemic. That's far from a condemnation of telehealth, though. Quite the opposite. In response to those reports, the AMA is now urging governors across the country to adopt the federal flexibility around telemedicine as a way to deal with the uptick in overdoses.

There's still time for the government to extend the current waivers. If it doesn't, it will mean that Boulder and Ophelia and other companies like them will have to go back to the old way of operating, serving fewer patients at the very moment when so many more need help.

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